BBL Chocolate II Agar- IVD for the isolation and cultivation of Neisseria species. Catalog (Ref) Number: 221267

FDA device recall Z-0473-2023 · posted 2022-12-09 · Open, Classified

Recall details

Recalling firm

Becton Dickinson & Co.

Reason for recall

Boxes contain a reduced concentration of Nicotinamide Adenine Dinucleotide and does not provide enough of the blood factors necessary to support Haemophilus growth. The reduction could cause a false negative result for Haemophilus isolation in a clinical specimen.

Action taken

BD initiated the recall on November 21, 2022 via Urgent Medical Device Correction Letter. to Distributors and Risk Managers. Letter states reason for recall, health risk and action to take: Immediately inspect your inventory for the specific catalog and lot number listed above. Affected product includes box numbers 0002 through 0097. These boxes correlate to timestamps on the plates of 11:34 through 13:51. Timestamps can be found on the bottom of the plate. The box number can be located on the 2. Share and post this recall letter within your facility network and forward to any customers to whom you may have distributed the product to ensure awareness. 3. Complete the attached Customer Response Form and return to the BD contact noted on the form whether or not you have any of the impacted material so that BD may acknowledge your receipt of this notification per FDA requirements. Distributors: As BD plans to notify all affected customers directly, please identify customers within your distribution network that purchased the affected product, as defined in this notification. Email an excel file listing of all customers to BDRC4@bd.com within 72 hours of receipt of this letter so that BD may initiate customer notification. Actions Taken by BD: BD will issue replacements following receipt of the completed Customer Response Form. Questions: North American Regional Complaint Center .Phone: 1-844-8BD-LIFE (1-844-823-5433) Fri 8:00am and 5:00pm CT or Email: productcomplaints@bd.com

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

JTY

Quantity affected

9,600 EA

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, India, Philippines.

Date initiated

2022-11-21

Date posted

2022-12-09

Location

Sparks, MD